3D Printed Drug Spritam Cleared By FDA

The medical industry is a fertile ground for some of the most promising and innovative uses for additive manufacturing. As the FDA begins to approve more 3D printed devices, other additive manufacturing applications like 3D printed tissue, organs and oral medications seem to be right around the corner.

3D printed drugs

That is why in 2015 it was no surprise when drug company Aprecia created Spritam (Levetiracetam), the first oral 3D printed drug to be approved by the FDA. Spritam is an oral epilepsy prescription therapy for the treatment of onset, myoclonic and primary generalized tonic-clonic seizures. It is available in dosages from 250 mg to 1,000 mg which ensures that as much of the market as possible is covered.

The 3DP technology originally engineered at M.I.T. (Massachusetts Institute of Technology) was a catalyst for the medication Aprecia created using their ZipDose Technology platform. Spritam, which was just recently released into the market, is designed to dissolve in the patient’s mouth with a small amount of liquid. This makes the epilepsy drug naturally geared toward the nearly half of the U.S. adult population that has difficulty swallowing their medications.

FDA approval is the key

The implications of the FDA approving the drug and the ability of additive manufacturing to make bespoke and individualised oral medications is important. This new technology from Aprecia could lead to more personalised medications, novel drug combinations and more accurate drug dosages for melt-in-your-mouth oral prescriptions. There has been enormous investment over the last few years in areas such as personalised medication which ensures that treatments are focused on each individual patient’s needs. There are high hopes that this will lead to not only better treatments but significant cost savings going forward.

It is highly likely that the fact the FDA has approved this particular process and this particular drug will lead to fast track clearance in other areas of the world. Time will tell but this could be a massive step forward for the medical profession with numerous opportunities opening up.

Proceed with caution

While this approval by the FDA does not mean that medications will be printed in a patient’s home, this is a giant step forward for 3D printing and a win for Aprecia. The cost of the machinery and the materials used will ensure it remains within the corporate sector for the foreseeable future. No doubt the FDA will also be monitoring the situation because ultimately these products need to be manufactured in a sterile environment using the correct ingredients. There are obviously some concerns about misuse of this groundbreaking technology but the positive aspects far outweigh any potential negative implications.

It is also very interesting to see Aprecia has already received over 50 pharmaceutical 3D printing related patents and plans to release more of their proprietary neurological medication in the near future. To say that 3D printing is akin to a new industrial revolution would not be an understatement as the potential is limitless.

Manufacturing a 3D printed drug

When you hear the term 3D printed drug it is difficult to get your head around what is actually being manufactured and how it is created. In reality it is a very simple process whereby numerous layers of a particular material are bound together to create a personalised drug treatment. The following video perfectly illustrates the process in 30 seconds: